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Article History

Received: 7 July 2022

Accepted: 3 November 2022

First Online: 28 November 2022

Declarations

:

: The study will be conducted in compliance with fundamental ethical principles and relevant national, EU, and international regulations. The sulfadoxine-pyrimethamine regimen is used by the National Malaria Control Program (NMCP) for IPTp-SP and pyronaridine-artesunate (Pyramax®) drug regimen that will be used in the phase 3 clinical trial has obtained the approval of the DRC National Ethics Committee (approbation reference: 169/CNES/BN/PMMF/2019 of the 13th of March 2020).Participants recruited for this clinical trial will be pregnant women in the 2nd trimester of their pregnancy regardless of their parity. They will only be included if they voluntarily accept after explanation from members of our research team and give their consent. In addition, the follow-up organized in this trial will allow them to have access to excellent quality care. The SP already used in IPTp is safe. Preclinical studies did not reveal any major problems, while treating a limited number of pregnant women with Pyramax® (22). DSMB experts will monitor the data collected and the safety of the process to discover possible issues. The study team will be proficient in detecting and managing AE that may arise during this study and will refer in accordance with national standards. In addition, clinical trial monitoring visits performed by experienced monitors will be held at pre-determined intervals.The study consent will be obtained for every participant after they have been informed on the nature of the clinical trial, potential risks, obligations, and benefits to which it is linked. The information provided will be written in French and Lingala (the local language spoken in the study site) in the ICF. The ICF will be available in two copies (the original kept by the investigator and the copy given to the participant). If the participant cannot read or write in French or Lingala, an independent witness will be present throughout the consent process and will sign and date the ICF, while the participant will affix her thumbprint as a sign of agreement.

: In the ICF, it is stated that data generated by this study will be published and made available to the public and the scientific community without any personal data of the participants being disclosed. Thus, the signing of the ICF before inclusion in the study is linked with the consent to publication.

: The authors declare that they have no competing interests.